(87 days)
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
The AtriCure Bipolar Coagulation System consists of two components: AtriCure Bipolar Coagulator and AtriCure Bipolar Electrosurgical Generator.
The Bipolar Coagulator is substantially equivalent to the predicate Bipolar Forceps in that each consists of a handle connected to a pair of grasping jaws with electrodes on each jaw arm. All the devices utilize the same bipolar Electrosurgical technology, i.e., radio frequency (RF) energy, to coagulate the tissue by heating. The Bipolar Coagulator contains a negative and positive electrode on opposite jaw arms. The function of the Bipolar Coagulator and predicate devices is the same, current flows from a negatively charged pole through the tissue to a positively charged pole. The Bipolar Coagulator is provided as a sterile single patient use device and is provided in a variety of shapes and sizes. The Bipolar Coagulator is constructed with standard biocompatible materials used in medical devices involved in tissue contact.
The Bipolar Coagulator is designed to grasp tissue between the electrodes. When the energy is applied, the tissue touching the electrodes is coagulated. The field of coagulation extends up to 2 mm from the electrode. Area of coagulated tissue will be up to 4 mm in width or up to 60 mm in length. Fully coagulated tissue can be achieved for tissue thickness less than 10 mm.
The Electrosurgical Generator is set to deliver 750 mA of current. As tissue coagulation proceeds the impedance increases. The voltage is set to not exceed 75 Volts. When a voltage of 75 Volts is reached, the impedance increases and current flow decreases with voltage maintained at 75 Volts. Impedance of 400 ohms typically indicates fully coagulated tissue. The unit will display impedance, current, voltage, and power on the front of the generator. The unit will also monitor the temperature of the coagulated tissue and has a range up to 125 degrees Celsius. The surgeon may also use this temperature reading as a point of reference to determine the extent of tissue coagulation.
The provided submission is a 510(k) summary for the AtriCure Bipolar Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant industrial/international standards. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or efficacy in a clinical or simulated environment.
The document primarily describes the device, its intended use, and lists predicate devices, along with compliance with various safety and quality standards (e.g., ISO, IEC, UL). These standards relate to electrical safety, biocompatibility, sterilization, and packaging, but not to the clinical performance or diagnostic accuracy of the device.
Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fulfilled from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards | |
| ANSI/AAMI HF 18 (Electrosurgical Devices) | Meets standard |
| ANSI C101-1992 (Leakage Current for Appliances) | Meets standard |
| AAMI ESI-1993 (Safe Current Limits for Electromedical Apparatus) | Meets standard |
| IEC/EN 60601-1 (General Requirements for Safety) | Meets standard |
| IEC/EN 60601-1+1 (Safety Requirements for Medical Device Systems) | Meets standard |
| IEC/EN 60601-2 (Electromagnetic Compatibility - Requirements and Tests) | Meets standard |
| IEC/EN 60601-2-2 (Safety of High Frequency Surgical Equipment) | Meets standard |
| UL 2601-1 (Standard for Safety: Medical Electrical Equipment) | Meets standard |
| UL 544 (Standard for Safety: Medical and Dental Equipment) | Meets standard |
| UL 498 (Standard for Safety: Attachment Plugs and Receptacles) | Meets standard |
| Biocompatibility Standards | |
| ISO 10993/EN 30993 (Biological Evaluation of Medical Devices) | Meets standard |
| Sterilization & Packaging Standards | |
| ISO 11607 (Packaging for Terminally Sterilized Medical Devices) | Meets standard |
| ISO 11137 (Sterilization of Health Care Products, Sterilization of Gamma Irradiation) | Meets standard |
| Quality Management Standards | |
| EN 46001 (Application of EN ISO 9001 to the Manufacture of Medical Devices) | Meets standard |
| Functional Capabilities | |
| Field of coagulation extends from electrode | Up to 2 mm |
| Area of coagulated tissue width | Up to 4 mm |
| Area of coagulated tissue length | Up to 60 mm |
| Fully coagulated tissue for thickness | Less than 10 mm |
| Generator current delivery | 750 mA |
| Voltage limit | Not to exceed 75 Volts |
| Impedance indicating fully coagulated tissue | 400 ohms (typically) |
| Generator display metrics | Impedance, current, voltage, power |
| Generator temperature monitoring range | Up to 125 degrees Celsius |
Note on this table: The "reported device performance" columns for the standards indicate that the device "meets" them. This implies successful testing against these standards, but the specific test results or detailed acceptance criteria for those tests are not provided in this 510(k) summary. The functional capabilities describe the physical characteristics and operational parameters of the device, which are inherent design specifications rather than performance metrics from a formal study proving efficacy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the submission. The submission primarily relies on demonstrating substantial equivalence to predicate devices and compliance with recognized industrial/international standards. There is no mention of a clinical or ex-vivo test set with specific sample sizes or data provenance for proving performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. No clinical or diagnostic performance study using expert-established ground truth is described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No clinical or diagnostic performance study requiring expert adjudication is described in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. This device is an electrosurgical system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The AtriCure Bipolar Coagulation System is a medical device for ablating and coagulating tissue, not a standalone algorithm. Its performance is intrinsically linked to its use by a human surgeon. The document describes the technical specifications and safety compliance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided in the context of a performance study establishing efficacy or diagnostic accuracy. The "ground truth" implicitly referred to would be the successful adherence to engineering and safety standards during testing, and the physical parameters of tissue coagulation as observed in bench testing or internal validation, but no formal 'ground truth' for clinical efficacy is reported.
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. This device is not an AI/ML algorithm that requires a training set with established ground truth.
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AtriCure Incorporated
510(k) SUMMARY ATRICURE COAGULATION SYSTEM 510(k) NOTIFICATION K010112 and K01XXXX
KO11722
General Information
AtriCure Medical Corporation Manufacturer: 6033 Schumacher Park Drive West Chester, OH 45069-3863 (513) 755-4100 Fax (513) 755-4108 Est. Req. No. XXXXXXXX
AUG 3 0 2001
Mark L. Friedman, Ph.D. Contact Person: Vice President of Quality Assurance & Regulatory Affairs AtriCure Medical Corporation
[to be added after 510(k) process]
Date Prepared:
Device Description
Class II Classification: AtriCure Bipolar Coagulation System Trade Name: Electrosurgical cutting and coagulation device and Generic/Common Name: Accessories 21CFR878.4400
Predicate Devices
-
- Ethicon Non-Stick Bipolar Forceps (K973384)
-
- Link Technology's Non-Stick Bipolar Forceps (K992931).
-
- The generator accessory is equivalent to the currently marketed Rita Model 1500 Electrosurgical RF Generator, which received clearance under K993944
-
- Somnus Medical Technologies Model S1 Electrosurgical Generator K000501
-
- CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930)
-
- Heartport Inc. Heartport Maze System (K970496)
-
- EndoCare Cryocare Cryosurgical System (K980110)
-
- CyroGen Cardiac Cryosurgical Unit (K974320)
-
- CyroGen Cryosurgical Unit and Accessories (K003050)
-
- Galil Medical Cryo-Hit 200(K991517)
-
- Galil Medical Cryo-Hit (K993965)
{1}------------------------------------------------
Indication For Use Statement
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
Product Description
The AtriCure Bipolar Coagulation System consists of two components: AtriCure Bipolar Coagulator and AtriCure Bipolar Electrosurgical Generator.
The Bipolar Coagulator is substantially equivalent to the predicate Bipolar Forceps in that each consists of a handle connected to a pair of grasping jaws with electrodes on each jaw arm. All the devices utilize the same bipolar Electrosurgical technology, i.e., radio frequency (RF) energy, to coagulate the tissue by heating. The Bipolar Coagulator contains a negative and positive electrode on opposite jaw arms. The function of the Bipolar Coagulator and predicate devices is the same, current flows from a negatively charged pole through the tissue to a positively charged pole. The Bipolar Coagulator is provided as a sterile single patient use device and is provided in a variety of shapes and sizes. The Bipolar Coagulator is constructed with standard biocompatible materials used in medical devices involved in tissue contact.
The Bipolar Coagulator is designed to grasp tissue between the electrodes. When the energy is applied, the tissue touching the electrodes is coagulated. The field of coagulation extends up to 2 mm from the electrode. Area of coagulated tissue will be up to 4 mm in width or up to 60 mm in length. Fully coagulated tissue can be achieved for tissue thickness less than 10 mm.
The Electrosurgical Generator is set to deliver 750 mA of current. As tissue coagulation proceeds the impedance increases. The voltage is set to not exceed 75 Volts. When a voltage of 75 Volts is reached, the impedance increases and current flow decreases with voltage maintained at 75 Volts. Impedance of 400 ohms typically indicates fully coagulated tissue. The unit will display impedance, current, voltage, and power on the front of the generator. The unit will also monitor the temperature of the coagulated tissue and has a range up to 125 degrees Celsius. The surgeon may also use this temperature reading as a point of reference to determine the extent of tissue coagulation.
The AtriCure Bipolar Coagulation System meets the following performance industrial/international standards.
ANSI/AAMI HF 18 ANSI C101-1992
«
Electrosurgical Devices American National Standard for Leakage Current for Appliances
{2}------------------------------------------------
| AAMI ESI-1993 | Safe Current Limits for ElectromedicalApparatus |
|---|---|
| ISO 10993/EN 30993ISO 11607 | Biological Evaluation of Medical DevicesPackaging for Terminally Sterilized MedicalDevices |
| ISO 11137 | Sterilization of Health Care Products,Sterilization of Gamma Irradiation |
| IEC/EN 60601-1 | Medical Electrical Equipment - Part 1: GeneralRequirements for Safety |
| IEC/EN 60601-1+1 | Medical Electrical Equipment - CollateralStandard: Safety Requirements for MedicalDevice Systems |
| IEC/EN 60601-2 | Medical Electrical Equipment - Part 1: GeneralRequirements for Safety 2: Collateral StandardElectromagnetic Compatibility - Requirementsand Tests |
| IEC/EN 60601-2-2 | Medical Electrical Equipment - Part 2-2:Particular Requirements for the Safety of HighFrequency Surgical Equipment |
| EN 46001 | Application of EN ISO 9001 to the Manufactureof Medical Devices |
| UL 2601-1 | Standard for Safety: Medical ElectricalEquipment |
| UL 544 | Standard for Safety: Medical and DentalEquipment |
| UL 498 | Standard for Safety: Attachment Plugs andReceptacles |
Summary
As contained in this 510(k) summary, the AtriCure Bipolar Coagulation System is substantially equivalent to the predicate devices identified.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping profiles facing right. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Mark L. Friedman, Ph.D. Vice President of Quality Assurance and Regulatory Affairs AtriCure Medical Corporation 6033 Schumacher Park Drive West Chester, Ohio 45069
Re: K011722
Trade/Device Name: AtriCure Bipolar Coagulation System Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: May 31, 2001 Received: June 4, 2001
Dear Dr. Friedman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Coonisions of the Act. The general controls provisions of the Act include requirements for annual provisions of article from the read manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mark L. Friedman, Ph.D.
This letter will allow you to begin marketing your device as described in your 510ks) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri miding of backan.com vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice tor your do need contact the Office of Compliance at additionally 809.10 for in Vitto diagnosus as rices, promotion and advertising of your device, (301) 594-4039. Addinonally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranuming by receired to perine Act may be obtained from the Division of Small information on your responsionnes ander the rise in its toll-free number (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-free number (8 Manufacturers international and Solass "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Susan Wacker Fox
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1 of_f
510(k) Number (if known): K011722
Device Name: AtriCure Bipolar Coagulation System
Indications For Use:
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) (Division Sigi-On)
Division of General, Restorative Division of Gical Devices
510(k) Number K011722
(Optional Format 3-10-98)
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.